Following an overnight fast of at least 10 hours, A single oral dose of one Cyclobenzaprine hydrochloride 10 mg tablet was administered with 240 mL of drinking water at ambient temperature during each period of the study under supervision of a trained Study Personnel.

During the course of the study safety parameters assessed were vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical parameters, serology and urine analysis) at baseline. Laboratory parameters of hematology and biochemistry were repeated at the end of the study.

A total of forty (40) subjects were enrolled in the study. Out of which thirty-four (34) subjects completed both the periods of the study.

Eligibility

Ages Eligible for Study:

18 Years to 45 Years (Adult)

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Were in the age range of 18-45 years.

Were neither overweight nor underweight for his height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.

Had voluntarily given written informed consent to participate in this study

Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.

Exclusion Criteria:

- Hypersensitivity or allergy to Cyclobenzaprine hydrochloride or related group of drugs.

Use of MAO Inhibitors in the past 2 weeks / history of Hyperthyroidism.

History of hypotension, dizziness, syncope or those who had previously experienced a hypotensive response to other medications.

History of any psychiatric illness which might impair the ability to provide written informed consent.

Regular smokers who smoked more than 10 cigarettes daily or had difficulty abstaining from smoking for the duration of each study period.

History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or had difficulty in abstaining for the duration of each study period.

Used any enzyme modifying drugs within 30 days prior to Day 1 of this study.

Participated in any clinical trial within 12 weeks preceding Day 1 of this study.

Subjects who, through completion of this study, would have donated and/or lost more than 350 mL of blood in the past 3 months.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778037